Recently, the State Drug Administration officially issued the "Announcement on Matters Related to the Registration and Filing of Cosmetics (Draft for Solicitation of Comments)".One of the core changes of this blockbuster document is the end of the cosmetic raw material submission code system that has been in operation for many years-when the product is registered for the record, the company no longer needs to fill in the raw material safety information documents, and the relevant information is transferred to the company's own archive for reference.This policy adjustment is not only the deepening of the reform in the field of cosmetics supervision, but will also profoundly affect the entire cosmetics industry chain, especially the supply chain management, filing process and quality control system of cosmetic raw materials.
To understand the significance of this change, we first need to review the background of the birth of the raw material submission code system.In 2021, with the formal implementation of the "Regulations on the Supervision and Administration of Cosmetics", China's cosmetics industry will enter an era of strong supervision.In order to solve the pain points of the industry such as opaque safety information of cosmetic raw materials, difficult supply chain traceability, and cumbersome filing process, the State Food and Drug Administration has launched a cosmetic raw material safety information service platform and established a raw material submission code system.
The release of this draft for solicitation of comments is an important measure for the regulatory authorities to adapt to the development needs of the industry and deepen the reform of “deregulation services”.The document is clear, and the safety-related information of cosmetic raw materials will be adjusted to be archived by the enterprise for reference. When the filing person submits the filing information, the safety-related information of cosmetic raw materials may not be uploaded, including the raw material submission code, raw material safety-related information (Annex 14), etc.).
Impact of change
(1) Enterprise side
For cosmetic registrants and filing persons, the most direct benefit of this change is the simplification of the filing process.In the past, from the formulation development of a cosmetic product to the completion of the filing, the filling and review of the raw material submission code was one of the longest time-consuming links.Enterprises need to contact raw material suppliers one by one to obtain the submission code, check the raw material safety information documents, and ensure that the submission code is exactly the same as the raw material information and formula information. Once there is any deviation, the filing review will not be passed, and the product launch time will be significantly delayed.
After the submission code is cancelled, the enterprise no longer needs to upload raw material safety information in the filing link, it only needs to archive the relevant information for reference.This adjustment will directly shorten the product filing cycle and greatly improve the filing efficiency.For companies, this means that the speed of new products to market is accelerated, they can respond to market demand faster, and seize consumer hotspots.Especially for categories with fast renewal and iteration such as skin care and makeup, the improvement of filing efficiency will directly translate into market competitiveness.
At the same time, the reduction of compliance costs is also an important benefit.Enterprises no longer need to invest a lot of manpower and time in the verification, filling and maintenance of the submission code, and there is no need to repeatedly modify the filing information due to the submission code problem, saving a lot of labor costs and time costs.For small and medium-sized cosmetics companies, this burden-reducing measure will effectively reduce the industry's entry threshold, stimulate market innovation vitality, and promote the diversified development of the industry.
In addition, for the management of the raw material supply chain, the cancellation of the submission code will also bring increased flexibility.In the past, when companies replaced raw material suppliers, they needed to re-obtain the submission code of the new supplier and re-fill in the filing information, which was cumbersome.Nowadays, companies only need to ensure that the raw materials of new suppliers meet the quality requirements and archive relevant safety information. There is no need to modify the filing information, which greatly improves the flexibility of supply chain management and helps companies optimize the supply chain structure and reduce procurement costs.
This policy adjustment is essentially a transformation of the supervision model: from the pre-supervision of ”pre-audit + submission code control" to the full-chain supervision of the main responsibility of the enterprise + post-verification.
The State Food and Drug Administration no longer provides raw material safety information service platform services and no longer discloses the submission of code information, which does not mean that supervision is lacking.On the contrary, the regulatory department will shift the focus of its work from cumbersome pre-audit to post-flight inspection, sampling inspection, risk monitoring and other links, through inspection, special remediation, etc., to conduct post-mortem verification of the raw material safety information archived by the enterprise.Once it is found that the archived information of the enterprise is untrue, incomplete, or uses raw materials that do not meet the requirements, it will be strictly investigated and dealt with in accordance with the law, and the main responsibilities of the enterprise will be severely investigated.
The transformation of this regulatory model can not only improve the effectiveness of supervision, so that regulatory resources are more concentrated on high-risk products and enterprises, but also force enterprises to strengthen internal quality control.For enterprises, the reduction of the burden on the filing link means that they need to assume more main responsibilities. It is necessary to establish and improve the whole process management system of raw material procurement, acceptance, archiving, and traceability to ensure that the safety information of raw materials is true, complete, and traceable.
Industrial chain impact
The cancellation of the raw material submission code system will have a profound impact on the entire cosmetics industry chain, from the production and supply of raw materials such as
Cosmetic Emollients, to the research and development and filing of cosmetic products, to the consumer experience of the terminal market, will usher in new changes.
(1) Raw material enterprises
For raw material production enterprises and domestic responsible persons for imported raw materials, the cancellation of the submission code system means that there is no need to invest a lot of resources in the declaration, maintenance and information update of the submission code, and more energy can be focused on raw material research and development, quality improvement and customer service.
In the past, one of the core tasks of raw material companies was to maintain the information of raw material submission codes, ensure that the information was accurate and updated in a timely manner, and at the same time respond to the query needs of a large number of cosmetic companies.Now that this burden has been lifted, raw material companies can invest more resources in the research and development and innovation of core raw materials such as
Emollients, improve the safety, efficacy and stability of raw materials, and develop new raw materials that are more in line with market demand.At the same time, raw material companies can also optimize their customer service systems, provide cosmetics companies with more comprehensive raw material safety information, technical support and quality assurance services, and strengthen cooperative relations with downstream companies.
In addition, the cancellation of the submission code will also promote fairer competition in the raw material market.In the past, some large raw material companies relied on the advantages of submission code resources to occupy more market share.Nowadays, the core competitiveness of enterprises will return to the quality of raw materials, technical services and price advantages. Small and medium-sized raw material enterprises can also rely on high-quality products to obtain more market opportunities and promote the innovation and development of the raw material industry.
(2) Cosmetic companies
For cosmetics companies, this change is not only to reduce the burden on the filing process, but also an opportunity to upgrade the enterprise management system.
On the one hand, the improvement of filing efficiency will accelerate the product development and listing process.After completing the product formula research and development, enterprises no longer need to wait for the submission code to be filled in and reviewed. They only need to complete the safety assessment, product inspection and other links to submit for the record, greatly shortening the new product launch cycle.This will promote companies to increase investment in research and development, accelerate product innovation, launch more effective skin care, makeup, and personal care products that meet consumer needs, and enrich the market supply.
On the other hand, enterprises must strengthen their main responsibilities and establish and improve the quality control system of raw materials.The deregulation of the filing link means that enterprises need to assume full responsibility for the safety of raw materials.Enterprises must establish a strict raw material procurement and acceptance system, and strictly audit the source, quality, and safety information of each batch of raw materials to ensure that the raw materials meet regulatory requirements.At the same time, a sound raw material safety information archiving system has been established to ensure that the safety information documents of all raw materials are true, complete and traceable, and are subject to post-mortem verification by regulatory authorities at any time.
(3) Terminal market
For end consumers, this policy adjustment will also bring real benefits.
First of all, the accelerated speed of product launch will allow consumers to experience the latest cosmetic products and technologies faster.Whether it is new effective ingredients, skin care formulas, or trendy makeup products, they can enter the market faster and meet consumer demand for new products.
Secondly, the reduction of corporate compliance costs will promote product prices to be more people-friendly.Part of the filing costs and labor costs saved by enterprises will be converted into product price advantages, allowing consumers to buy high-quality cosmetic products at more affordable prices.
Finally, the upgrading of the regulatory model will further regulate the market order and protect the rights and interests of consumers.Through post-incident verification, flight inspections, etc., the regulatory authorities strictly crack down on illegal acts such as counterfeit and shoddy products and illegal additions, so as to ensure that the products on the market are safe and effective, so that consumers can buy with confidence.
Corporate Response Guide
In the face of this policy change, cosmetics companies need to seize the opportunity, take the initiative to adjust, while enjoying the burden of filing, build a solid compliance bottom line, and achieve high-quality development of enterprises.
1. Optimize internal processes and improve filing efficiency
2. Strengthen the control of raw materials and improve the archiving system
3. Strengthen team building and improve compliance capabilities
4. Deepen supply chain cooperation to ensure the safety of raw materials
The end of the era of raw material submission code is an important sign of the continuous improvement of China's cosmetics regulatory system and the maturity of the industry.This policy adjustment is not only a response to the development needs of the industry, but also a strengthening of the main responsibilities of the enterprise.
Standing at a new starting point for the development of the industry, China's cosmetics industry will take responsibility as the cornerstone and innovation as the driving force to continuously improve product quality and safety, and provide consumers with better quality and safer cosmetic products.
Hubei Mingya New Material Technology Co., Ltd.
